Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Acronym

Study hypothesis

Acidic and neutral oligosaccharides supplemented enteral nutrition has a positive effect on infectious morbidity, modulation of the immune response, postnatal adaptation of the gut, feeding tolerance and short-term outcome in Very Low Birth Weight (VLBW) infants.2006 literature review on http://www.ncbi.nlm.nih.gov/pubmed/16677741.

Ethics approval

Medical Ethics Committee VU Medical Centre, 15/02/2007

Study design

Randomised placebo-controlled factorial double-blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Prebiotics, gastrointestinal tract, preterm infants, immune effects

Intervention

Enteral supplementation of acidic and neutral oligosaccharides (20%/80% mixture) in a maximum dose of 1.5 g/kg/day during the first month of life.

Intervention type

Supplement

Phase

Not Specified

Drug names

Enteral supplementation of acidic and neutral oligosaccharides

Primary outcome measures

1. The effect of acidic and neutral oligosaccharides supplemented enteral feeding on infectious morbidity2. The incidence of serious infections, using the previously described criteria for serious infections in preterm infants at high risk for serious infections, are prospectively documented from birth until discharge home

Secondary outcome measures

The effect of acidic and neutral oligosaccharides supplemented enteral nutrition on feeding tolerance, short-term outcome, postnatal adaptation of the gut and modulation of the immune response

Overall trial start date

01/04/2007

Overall trial end date

01/04/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Infants born with a gestational age of less than 32 weeks and/or a birthweight of less than 1500g